A Phase 2/3 interventional study of Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter and Paclitaxel drug-coated balloon angioplasty in Popliteal Artery Disease and Superficial Femoral Artery Disease, sponsored by Concept Medical Inc.. Not yet recruiting. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Concept Medical Inc. · Phase 2/3, Interventional, and Treatment
Percutaneous Transluminal Angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries. The long-term success of bare balloon PTA in the femoropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by local antiproliferative drug delivery via the PTA balloon catheter.
The rationale of this trial is based on the hypothesis that the usage of the MagicTouch drug-coated balloon (DCB) is at least equal (non-inferior) with regard to efficacy and safety in comparison with a clinically well-established paclitaxel drug-coated balloon (PTX DCB).
The objective of this prospective, randomized, multi-center trial is to compare the Magic Touch® DCB with PTX DCBs for treatment of high-grade stenotic or occluded lesions in supeficial femoral artery (SFA) and/or P1 segment of the popliteal artery in PAD patients.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 478 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Concept Medical Inc. is the lead sponsor of 9 studies on the registry; 7 are open to participants now.
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GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
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Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to this arm will receive the experimental device during the angioplasty procedure to treat the affected vessel lesion that was occluded or stenosed.
Combination Product: Sirolimus (RAPAMUNE) drug-coated balloon angioplasty catheter
Subjects randomized to this arm will receive the control device during the angioplasty procedure to treat the affected vessel lesion that was occluded or stenosed.
Combination Product: Paclitaxel drug-coated balloon angioplasty
Sirolimus is used outside the United States to block cell growth, cell proliferation (especially T-cells), and angiogenesis (new blood vessel formation). This experimental device uses proprietary technology to adhere sirolimus to the balloon catheter, deliver it to the affected vessel, and ultimately be absorbed by the surrounding tissue.
Paclitaxel, which is used in cancer chemotherapy for various indications, is a drug that disrupts normal microtubule function and prevents neointimal hyperplasia by inhibiting smooth muscle cell migration, proliferation, and extracellular matrix secretion and is currently used in the United States.
Vessel Patency Rate & Freedom from Post-Procedure Complications after One Year (12 months)
Measured by the absence of clinically driven target lesion revascularization (CD-TLR) due to symptoms and a drop of ABI of ≥ 20% or \> 0.15 when compared to post-procedure or restenosis with PSVR \> 2.4 evaluated by duplex ultrasound. Also, a composite of freedom from device and procedure-related death through 12-months post procedure, as well as freedom from target limb major amputation and clinically driven target vessel revascularization
Time frame: One year from index procedure
Long-term Safety and Efficacy of the Treated Vessel
1. Vesel patency at 6, 12, 24, and 48-month \& free of clinically-driven TLR at 1, 6, 12, 24, 36, 48, and 60-month 2. Sustained clinical improvement: an improvement shift in the Rutherford classification of at least one category in amputation and TVR-free surviving subjects at 12 months 3. Change in walking capacity assessment from pre-procedure to the respective follow-up visits 4. Duplex-defined binary restenosis (PSVR \> 2.4) of the target lesion post-procedure and at 6, 12, \& 24-months, or at any time of re-intervention 5. Hemodynamic improvement is defined as an increase in resting ankle brachial index (ABI) from pre-procedure to discharge, 6, 12, 24, and 48-months 6. Change in quality-of-life (QoL) assessment by VascuQol questionnaire and EQ5D-5L index questionnaire from pre-procedure through applicable follow-up visits 7. All-cause mortality at 1, 6, 12, 24, 36, 48, and 60-month 8. Target limb major amputation at 1, 6, 12, 24, 36, 48, and 60-month
Time frame: Up to five years after index procedure
No study locations are listed for this record.
Plan to share: No — This may change, but at this time, the results are for potential future marketing and sales of the investigational device pending government approval.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sirolimus
Concept Medical Inc.